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Artixio

Medical Device Regulatory Consultant In Japan

Medical Devices Regulatory Services in Japan

Artixio helps you meet PMDA requirements with end-to-end regulatory support for medical devices in Japan.

Artixio’s Medical Devices Registration Services in Japan

Artixio provides seamless regulatory services for commercialization of your medical device in the Japanese market. Our experienced professionals in Japan help you streamline the regulatory journey for your MedTech product. We assure timely compliance with the stringent guidelines the PMDA. Our dedicated team provides assistance right from product conceptualization till product surveillance.

Key Regulations for Medical Devices in Japan

Our Medical Devices Registration Process in Japan

Our Regulatory and Market Access experts based in Japan, coupled with the global Regulatory projects team, have assisted over a hundred pharmaceutical, medical devices, diagnostics, cosmetics, nutraceuticals, supplements, and veterinary products successfully register and maintain compliance with the PMDA in Japan. Artixio’s local experts are committed to assist you register and launch your device medical device in Japan. Coupled with the Artixio’s intelligence-based services platform, Dvarka, innovators and manufacturers around the globe have benefited by seamlessly managing the regulatory strategy for the product development and commercialization value chain.
For Medical Devices, from strategic planning and registration to post-market compliance, Artixio provides high-quality efficient regulatory affairs services to support your business in Mexico.
Support for medical device regulatory in japan

Why Choose Artixio as Your Medical Device Consultant in Japan?

Compliance consulting services company
We understand the complexities of PMDA pathways and guide you through every step.
Compliance consulting services company
Work with professionals who know Japan’s regulatory culture, not just the rules.
Compliance consulting services company
Local experienced staff with 15-35+ years of experience in Japan
Compliance consulting services company
Regulatory intelligence driven solutions for device compliance
Compliance consulting services company
End to End Support from Product Conceptualization to Launch and Post Market Support 
Compliance consulting services company
Support with Japan-specific QMS audits — no surprises, just smooth compliance.
Compliance consulting services company
KPI based, continual process excellence   
Compliance consulting services company
Wide Therapeutic Areas, Formulation and Route of Administration Experience   
Compliance consulting services company
We manage your pre-market approvals and stay with you for post-market vigilance.
Compliance consulting services company
Our local and global teams stay responsive, so your timelines don’t suffer.

FAQs

What is the Shonin process?
Shonin process is the approval process for the class III and class IV medical device that involves full PMDA review process.
A D-MAH allows the foreign manufacturer to own a product ownership but have a Japanese company handle its regulatory duties.
Yes, all the medical devices sold in Japan should include Japanese label.
The approval period of medical devices in Japan depends upon the class of the device such as class I device requires few days; class II device requires 4-6 months whereas class III devices take 9-18 months.

Regulatory Expertise Across
Multiple Countries

India Artixio – Regulatory affairs consulting expert
India
Vietnam Artixio – Regulatory affairs consulting expert
Vietnam
Mexico Artixio – Regulatory affairs consulting expert
Mexico​
Vietnam Artixio – Regulatory affairs consulting expert
Vietnam
US FDA Professional life sciences consulting – Artixio
United States
Brazil Artixio – Regulatory affairs consulting expert
Brazil
Europe Artixio – Regulatory affairs consulting expert
Europe
Malaysia Artixio – Regulatory affairs consulting expert
Malaysia
Taiwan Artixio – Regulatory affairs consulting expert
Taiwan
China Artixio – Regulatory affairs consulting expert
China
Thailand Artixio – Regulatory affairs consulting expert
Thailand
Philippines Artixio – Regulatory affairs consulting expert
Philippines

Industries we serve

Regulatory and compliance expert – Artixio

Pharmaceuticals

Cosmetics regulatory consulting – Artixio

Cosmetics

Nutrition

Medical device regulatory services – Artixio

Medtech

Biologics regulatory consulting – Artixio

Biologics

Veterinary regulatory consulting – Artixio

Veterinary

Blogs

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February 24, 2026
HSA Singapore Investigational Product Management Guidance

HSA Singapore Investigational Product

For locally registered products in Singapore, the management of investigational product (IP) for clinical...

February 23, 2026
Strategic Criteria for Selecting a Regulatory Consultant in Thailand

Strategic Criteria for Selecting

All industries in Thailand, including cosmetics, food, medical devices, and nutrition, develop very fast,...

January 28, 2026

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